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Gemcision™ Keratome, Super Sharp, 2.2mm Width/Box of 5
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Gemcision™ Keratome, Super Sharp, 2.2mm Width/Box of 5 FDA UDI
- Generic Name
- Ophthalmic knife, reusable FDA UDI
- Device Name
- Gemcision™ Keratome, Super Sharp, 2.2mm Width/Box of 5 FDA UDI
- Model / Reference
- 7920-K22b FDA UDI
- Description
- Gemcision™ Keratome, Super Sharp, 2.2mm Width/Box of 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840096207170 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gemcision™ Keratome, Super Sharp, 2.2mm Width/Box of 5 by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Katalyst Surgical, Llc
Sources (1)
- FDA UDI b8659288-bf08-4de9-8c96-7719bd9e5665 34 fields · synced Jun 1, 2026